1. Name Of The Medicinal Product
Human Tetanus Immunoglobulin, 100 IU/ml sterile solution
2. Qualitative And Quantitative Composition
Human Tetanus Immunoglobulin Ph.Eur. contains human protein, 40-180 g/L of which at least 95% is IgG. The concentration of specific IgG to tetanus toxin is not less than 100 IU/ml in nominal 250 IU vials. The correct volume to give the stated potency is overprinted on the label.
This product is prepared from plasma from screened donors. Donors are selected from the USA.
For excipients, see section 6.1.
3. Pharmaceutical Form
Solution for injection.
4. Clinical Particulars
4.1 Therapeutic Indications
1. Post-exposure prophylaxis:
Immediate prophylaxis after tetanus prone injuries in patients not adequately vaccinated, in patients whose immunisation status is not known with certainty, and in patients with severe deficiency in antibody production or vaccinated patients with high risk wounds.
2. Therapy of clinically manifest tetanus.
Active tetanus vaccination should always be administered in conjunction with tetanus immunoglobulin unless there are contraindications or confirmation of adequate vaccination.
4.2 Posology And Method Of Administration
4.2.1 Posology
Prophylaxis of tetanus prone wounds:
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Therapy:
For treatment of tetanus, the recommended dose is 150 IU/kg body weight in multiple sites. This product is NOT suitable for intravenous administration.
The volume of solution that needs to be administered to give 250 IU is stated on the label.
DO NOT EXCEED THE RECOMMENDED DOSE.
4.2.2 Method of administration
Human Tetanus Immunoglobulin should be administered via the intramuscular route.
If a large volume (> 2mL for children or> 5 mL for adults) is required, it is recommended to administer this in divided doses at different sites.
When simultaneous vaccination is necessary, the immunoglobulin and the vaccine should be administered at two different sites.
For prophylaxis, if intramuscular administration is contra-indicated (bleeding disorders), the injection can be administered subcutaneously. However, it should be noted that there are no clinical efficacy data to support administration by the subcutaneous route.
For acute therapy, if intramuscular administration is not clinically appropriate, an alternative intravenous product may be used if available.
4.3 Contraindications
Hypersensitivity to any of the components.
Hypersensitivity to human immunoglobulins.
4.4 Special Warnings And Precautions For Use
Ensure that Human Tetanus Immunoglobulin is not administered into a blood vessel, because of the risk of shock
.
True allergic reactions are rare.
Human Tetanus Immunoglobulin contains a small quantity of IgA. Individuals who are deficient in IgA have the potential for developing IgA antibodies and may have anaphylactic reactions after administration of blood components containing IgA. The physician must therefore weigh the benefit of treatment with Human tetanus Immunoglobulin against the potential risk of hypersensitivity reactions.
Rarely, human tetanus immunoglobulin can induce a fall in blood pressure with anaphylactic reaction, even in patients who have tolerated previous treatment with human immunoglobulin.
Suspicion of allergic or anaphylactic type reactions requires immediate discontinuation of the injection. In case of shock, standard medical treatment for shock should be implemented.
Standard measures to prevent infections resulting from the use of medicinal products prepared from human blood or plasma include selection of donors, screening of individual donations and plasma pools for specific markers of infection and the inclusion of effective manufacturing steps for the inactivation/removal of viruses. Despite this, when medicinal products prepared from human blood or plasma are administered, the possibility of transmitting infective agents cannot be totally excluded. This also applies to unknown or emerging viruses and other pathogens.
The measures taken are considered effective for enveloped viruses such as HIV, HBV and HCV. The measures taken may be of limited value against non-enveloped viruses such as HAV and parvovirus B19.
There is reassuring clinical experience regarding the lack of hepatitis A or parvovirus B19 transmission with immunoglobulins and it is also assumed that the antibody content makes an important contribution to the viral safety.
It is strongly recommended that every time that Human Tetanus Immunoglobulin is administered to a patient, the name and batch number of the product are recorded in order to maintain a link between the patient and the batch of the product.
4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction
Live attenuated virus vaccines
Immunoglobulin administration may interfere with the development of an immune response to live attenuated virus vaccines, such as rubella, mumps, and varicella, for a period of up to 3 months. After administration of this product, an interval of at least 3 months should elapse before vaccination with live attenuated virus vaccines. In the case of measles, this impairment may persist for up to 5 months.
Interference with serological testing
After injection of immunoglobulin, the transitory rise of the various passively transferred antibodies in the patient's blood may result in misleading positive results in serological testing.
Passive transmission of antibodies to erythrocyte antigens, e.g. A, B, D, may interfere with some serological tests for red cell antibodies, for example the antiglobulin test (Coombs' test).
4.6 Pregnancy And Lactation
The safety of this medicinal product for use in human pregnancy has not been established in controlled clinical trials. Clinical experience with immunoglobulins suggests that no harmful effects on the course of pregnancy, or on the foetus and the neonate are to be expected.
4.7 Effects On Ability To Drive And Use Machines
No effects on ability to drive and use machines have been observed.
4.8 Undesirable Effects
There are no robust data on the frequency of undesirable effects from clinical trials. The following undesirable effects have been reported with intramuscular immunoglobulins:
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Anaphylactic reactions occur rarely and are more likely in patients who have antibodies to IgA, or who have had an allergic reaction after blood transfusion or treatment with plasma derivatives.
As with all intramuscular injections, some short term discomfort can be expected at the injection site and in rare instances local induration, which can be minimised by deep intramuscular injection.
For risk of transmission of virus infections, see Section 4.4.
4.9 Overdose
Consequences of an overdose are not known.
5. Pharmacological Properties
5.1 Pharmacodynamic Properties
Pharmacotherapeutic group: immune sera and immunoglobulins: Human Tetanus Immunoglobulin. ATC code: J06B B02.
Human tetanus Immunoglobulin contains mainly immunoglobulin G (IgG) with a specifically high content of antibodies against the toxin produced by the bacteria clostridium tetanus.
5.2 Pharmacokinetic Properties
Human tetanus immunoglobulin for intramuscular use is bioavailable in the recipient's circulation after a delay of 2-3 days.
Human tetanus immunoglobulin has a half-life of about 3 – 4 weeks. This half-life may vary from patient to patient.
IgG and IgG-complexes are broken down in the reticuloendothelial system.
5.3 Preclinical Safety Data
Human Tetanus Immunoglobulin is a preparation of human plasma proteins, so safety testing in animals is not particularly relevant to the safety of use in man. Acute toxicity studies in rat and mouse showed species specific reactions which bear no relevance to administration in humans. Repeated dose toxicity testing and embryo-fetal toxicity studies are impracticable due to the induction of, and interference with antibodies to human protein. Clinical experience provides no evidence of tumourigenic and mutagenic effects of immunoglobulins.
6. Pharmaceutical Particulars
6.1 List Of Excipients
Sodium chloride, Glycine and Sodium acetate
6.2 Incompatibilities
This medicinal product must not be mixed with other medicinal products.
6.3 Shelf Life
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6.4 Special Precautions For Storage
Human Tetanus Immunoglobulin should be stored in the original container at 2°C to 8°C. Storage for up to one week at ambient temperatures (25°C) in the original container is not detrimental. DO NOT FREEZE.
Store in the original vial. Keep vial in the outer carton in order to protect from light.
6.5 Nature And Contents Of Container
Neutral borosilicate glass vial (type I Ph.Eur.) with overseal consisting of a halobutyl rubber wad (type I Ph.Eur.), clear lacquered aluminium skirt and flip-off polypropylene cap.
6.6 Special Precautions For Disposal And Other Handling
The product should be brought to room or body temperature before use.
The colour can vary from colourless to pale-yellow and is either clear or slightly opalescent. Do not use solutions that are cloudy or have deposits.
Any used product or waste material should be disposed of in accordance with local requirements.
7. Marketing Authorisation Holder
Bio Products Laboratory
Dagger Lane
Elstree
Hertfordshire
WD6 3BX
United Kingdom.
Tel: +44 (0)20 8258 2200
Fax: +44 (0)20 8258 2608
Email: info@bpl.co.uk
8. Marketing Authorisation Number(S)
PL 08801/0011
9. Date Of First Authorisation/Renewal Of The Authorisation
February 1992
10. Date Of Revision Of The Text
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